Decrease Emergence Agitation and Provide Pain Relief for Children Undergoing Tonsillectomy & Adenoidectomy

NCT00468052 | Completed Phase 3 Results

• 1 other identifier: 0120060313
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

Pediatric tonsillectomy (with or without adenoidectomy) is a brief but painful surgery carried out in children who very often also present with obstructive sleep apnea. To provide pain relief, i.e. analgesia, current practice relies on opioids , e.g., morphine or fentanyl. These narcotics are known to depress respiration and to increase the incidence of post-operative nausea and vomiting. These side effects are worrisome in this patient cohort. An alternative medication, dexmedetomidine, may have an opiate sparing effect and has a high safety profile in adults as well as in sedation in children. The purpose of this study is to determine if intravenous dexmedetomidine given as an infusion during general anesthesia for tonsillectomy or adenotonsillectomy reduces the incidence and severity of emergence agitation, improves analgesia and reduces nausea and vomiting in the 60 minutes following surgery.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; tonsillectomy; adenoidectomy

Outcome Measures

Primary Outcomes (2)

• Emergence Agitation and Pain

  emergence agitation and pain will be assessed. Pediatric Anesthesia Emergence Delirium Scale (PAED) range 0-20 a lower score indicates the child is calm and the higher score indicates severe agitation. Cole Agitation Scale was employed which is a 5 point Likert scale. Parameters ranging 1 to 5 1=child is calm and 5 =the child is severly agitated . Objective Pain Score range is 0-10 (higher score the greater pain). 3 Parameters are captured systolic b/p,crying, movements, agitation , complaints of pain

  On arrival to PACU and 2 hours postoperatively

• Duration of Agitation

  Cole EA scale 1=calm , 5=unconsolable

  on arrival to PACU and for 2 hours postoperatively

Secondary Outcomes (5)

• Hemodynamic Stability

  intraoperatively

• Time to Awaken

  at end of surgery

• Time to Extubation

  at end of surgical procedure

• Number of Participants With SpO2 < or Equal to 95%

  on arrival to PACU and 2 hours postoperatively

• Participants Requiring Morphine Rescue in PACU

  arrival in PACU to 2 hours postoperatively

Study Arms (2)

fentanyl

ACTIVE COMPARATOR

fentanyl bolus 1ug.kg-1

Drug: fentanyl

dexmedetomidine

EXPERIMENTAL

dexmedetomidine 2ug.kg-1 over 10 min followed by 0.7ug.kg-1.h-1

Drug: dexmedetomidine

Interventions

dexmedetomidine DRUG

2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion

Also known as: Precedex

dexmedetomidine

fentanyl DRUG

1 microgram/kilogram as a bolus

Also known as: Sublimaze

fentanyl

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ages 2-10 ASA rating of I-III undergoing general anesthesia tonsillectomy with and without adenoidectomy

You may not qualify if:

• diagnosis of anxiety disorder or chronic pain syndrome chronic disabilities or developmental delays are currently on psychotherapeutic or sedating medication are on chronic pain medication or opiate any known adverse effect to the study drug any known cardiac abnormalities

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead

Study Sites (1)

UMDNJ University Hospital

Newark, New Jersey, 07103, United States

Location

Related Publications (1)

• Isik B, Arslan M, Tunga AD, Kurtipek O. Dexmedetomidine decreases emergence agitation in pediatric patients after sevoflurane anesthesia without surgery. Paediatr Anaesth. 2006 Jul;16(7):748-53. doi: 10.1111/j.1460-9592.2006.01845.x.

  PMID: 16879517 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Dexmedetomidine; Fentanyl

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Results Point of Contact

• Title: Anuradha Patel, MD
• Organization: UMDNJ

patelan@umdnj.edu

973 972-5254

Study Officials

• Anuradha Patel, MD

  University of Medicne & Dentistry of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2007
• First Posted: May 1, 2007
• Study Start: March 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: December 5, 2016
• Results First Posted: October 11, 2016

Record last verified: 2015-09

Locations

US (1)